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New treatment option for Leukemia, Myeloid, Acute
Official title MB-dNPM1-TCR.1 in Relapsed/Refractory AML
ClinicalTrials.gov ID: NCT06424340
What this study is testing
What is MB-dNPM1-TCR.1?
MB-dNPM1-TCR.1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leukemia, myeloid, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Phase I/II, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR) specific for dNPM1 peptides restricted to human leukocyte antigen (HLA) A\ 02:01 in patients with relapsed or refractory AML.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Patients must be able to understand and be willing to give signed informed consent
- Relapsed or refractory acute myeloid leukemia (last disease staging within 4 weeks prior to screening) without standard treatment options defined as:
- No morphological CR or extramedullary AML after at least two courses of intensive chemotherapy, decitabine or other standard therapy or
- MRD positive after at least two courses of intensive chemotherapy or other standard therapy and not eligible for allogeneic stem cell transplantation...
You likely can't join if
- Pregnant or breast feeding women.
- Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2 or Treponema Pallidum.
- Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe...
- Use of systemic immune suppression including, but not limited to: immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent...
- Unwillingness or inability to comply with procedures required in this clinical trial protocol.
- Uncontrolled life-threatening infections or uncontrolled disseminated intravascular coagulation; however, if these problems resolve, the start of...
See the full eligibility criteria
- Age ≥ 18 years
- Patients must be able to understand and be willing to give signed informed consent
- Relapsed or refractory acute myeloid leukemia (last disease staging within 4 weeks prior to screening) without standard treatment options defined as:
- No morphological CR or extramedullary AML after at least two courses of intensive chemotherapy, decitabine or other standard therapy or
- MRD positive after at least two courses of intensive chemotherapy or other standard therapy and not eligible for allogeneic stem cell transplantation or
- Relapsed bone marrow or blood disease or extramedullary AML after CR after first line treatment and not eligible to undergo allogeneic stem cell transplantation or
- Bone marrow, blood, extramedullary AML relapse or non-response or MRD positivity after allogeneic stem cell transplantation and not eligible to receive Donor Lymphocyte Infusion (DLI) according to local standards...
- Positive for HLA-A\ 02:01 according to genotyping results.
- AML has NPM1 mutation which is recognized by dNPM1-TCR.1 and for which a specific Q-PCR is available for disease monitoring.
- Number of circulating WBC above 1x109/L with less than 50% leukemic blasts and 0.03 x 109 CD8+ T cells/L.
- Life expectancy of at least 3 months.
- ECOG performance status 0-3.
- Negative pregnancy test in women of childbearing potential.
- For fertile men and women, agreement to use highly effective contraceptive methods during the trial.
- Pregnant or breast feeding women.
- Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2 or Treponema Pallidum.
- Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe complications of trial participation at the discretion of the investigator.
- Use of systemic immune suppression including, but not limited to: immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of 0.5 mg prednisone/kg body weight per day, or higher). Inhaled...
- Unwillingness or inability to comply with procedures required in this clinical trial protocol.
- Uncontrolled life-threatening infections or uncontrolled disseminated intravascular coagulation; however, if these problems resolve, the start of treatment can be initiated on a delayed schedule.
- people currently on any other IMP (including within the last 30 days before start of treatment).
- Current use of high dose immunosuppression for immune disorders interfering with T cell function (on discretion of the investigator).
- Known hypersensitivity against any drug of the mandatory trial procedures.
- Serum creatinine ≥ 2.0 × ULN or eGFR \< 30 mL/min calculated according to the modified MDRD formula.
- BMI ≥40
- Has received vaccination with live vaccines 6 weeks prior to treatment
- Major surgery less than 30 days before start of treatment.
- Committal to an institution on judicial or official order.
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.